PACKAGING AND LABELING HELP FIGHT DRUG COUNTERFEITS

In the U.S.Food and Drug Administration’s ongoing battle against counterfeit drug products, the latest FDA guidance is aimed directly at packaging techniques.In a July guidance document to industry, the FDA set forth some suggestions for incorporating so called “physical-chemical identifiers” PCIDs into solid oral dosageform drug products and paid particular attention to those that might migrate from packaging or container labeling.The FDA defines a PCID as a product with some unique physical and or chemical characteristic that is added to the dosage form of a drug product and which “makes it possible to detect and authenticate legitimate dosage forms and identify counterfeits.”These so-called PCIDs can include inks, pigments, flavors, or molecular taggants, says the FDA. And the agency expects that many of them would be made of existing substances used in food additives, colorants, or drug products’ excipients.The FDA’s guidance document, entitled “Incorporation of Physical-Chemical Identifiers Into Solid Oral Dosage Form Drug Products For Anticounterfeiting,” is primarily concerned with helping drug makers and applicants for new drug approvals incorporate relevant information about their PCIDs into new drug applications, supplemental applications, and annual reports submitted to the FDA.The guidance does not attempt to address radio frequency identification RFID.Counterfeits have tended to be a bigger problem overseas than in the U.S., though it is a concern here, and not just when drugs are imported. The FDA has always recognized the importance of packaging technologies as potential solutions, including but not limited to RFID.Confirming the authenticity of any individual package of drugs, or, when possible, even an individual dosage, is the essence of thwarting counterfeits. In the complex distribution network through which drug products travel, opportunities abound to introduce counterfeit product into the mix.Counterfeits can come in many forms. For example, they might be products that are just imitations, and literally lack the right ingredients, or are out-of-date versions of the real thing, or are otherwise diverted from the ordinary authorized distribution pathways. It is a recognized phenomenon that authentic and appropriate products are often mixed with inauthentic counterfeits, meaning the confirmation of authenticity often involves measures going to the individual dosage level. Hence, ideas like PCIDs.As for PCIDs that are added to packaging or labeling of drug products in solid oral dosage form, the FDA makes specific recommendations on how to evaluate toxicological concerns and offers guidance on when and how to report or request approval of the addition of a PCID. The agency points out that, as expected, its “toxicological concerns are mitigated if the added substances is a permitted direct or indirect food additive,” or listed in the FDA’s Inactive Ingredient Guide.If the substance you want to use as a PCID in packaging is not the subject of known toxicological information, the packager should, says the FDA, determine that there won’t be migration of the substance into the products. If some interaction of the PCID with the product is expected, and toxicological concerns may result, the FDA suggests packagers contact the agency to discuss the issues. If the toxicology of the substance hasn’t been established, and the potential for its migration exists, the FDA says the drug product with that PCID in it would require a prior approval supplement before marketing.When it comes to PCIDs in solid oral dosage-form products, the FDA is hoping to help industry follow one of its key pieces of advice: Use a multifaceted approach to counterfeiting in order to stay at least one step ahead of counterfeiters.

via Healthcare Packaging – December 2009 : ANTI-COUNTERFEITING: WHEN PACKAGING AND LABELING HELP FIGHT DRUG COUNTERFEITS.

Below is a really interesting technological packaging advancement that is truly exciting and could have major benefits in the healthcare and pharma packaging & clinical trials sectors. Design Cognition also believe that this technology has further application in other dosage forms and sectors and is working with DSM TCG & GP Solutions (UK) Ltd to develop the OtCMâ„¢ and Dose Guardâ„¢ technologies in innovative ways to meet the demands of end-users and industry and bring this product to market in a viable & cost-effective manner.

Please contact me (chris@designcognition.com) if you’d like more information or come and visit us at Packaging Innovations at the NEC, Birmingham UK on 24th or 25th Feb (stand 582), where we can discuss in more detail. You can register HERE.  Chris Penfold

When was the last time you forgot to take your medication? Odds are that it was within the last week. This makes you part of the millions of patients who don’t take their medications as prescribed by their physician. Medication non-adherence, or mal-compliance, as it is commonly called, is a problem that disrupts the healthcare system in many ways. If you don’t take your medication odds are that you won’t get the full benefit of the treatment. As former US surgeon general Dr. C. Everett Koop said, “Drugs don’t work in people who don’t take them”. In the worst case, you could be among the patient population who are hospitalized as a result medication non-adherence. The cost to the healthcare system? Phenomenal! Mortality count? Sinister! Morbidity rates? Unacceptable!

At its root, this problem, like many, is a problem of human behaviour. Even Hippocrates (460-377 BC), the “Godfather of Medicine”, gave early warnings of the non-compliance issues to his students and colleagues. (”Keep watch for that fault in patients which makes them lie about the taking of things prescribed.”). Even though we are “creatures of habit”, we often lose momentum when taking medications, especially for chronic conditions.

The Non-Compliance Money Waste List

There have been several attempts at using technology to influence compliance rates. As one scans the Web looking for potential help, some solutions that arise include:   (1) A variety of medication reminders that will beep, blip or blurt when it is time to take your medication. (2) A variety of devices that can track the number of times a medication dosage has been removed from a medication pack or a medication container (USA) that has been opened. The data collected can be downloaded at the doctor’s office or pharmacy to check compliance statistics. (3) A variety of devices that can remind the patient to take their medications and confirm that they have taken it by pressing a button to send the data.  (4) A miscellaneous group of reminder devices with alarms, like automated pill boxes or wrist watches.

OtCM™ -  Objective therapy Compliance Measurement.

One of the weaknesses of these approaches is that one can never guarantee that the patients have taken their medicine after an alarm. In fact, one can’t detect if the medication unit dosage has been taken, or if the medication unit dosage has even been taken at the right time.

A new technology has arrived that has the potential to dramatically impact the therapy compliance rates for individuals, particularly seniors, as they go about their daily lives. The name of this technology is OtCM™, Objective therapy Compliance Measurement, using the most recent RFID/NFC (Radio Frequency Identification, Near Field Communication) technology, including embedded sensor functionalities, and combined with printed organic electronics.  The OtCM™ application was invented by Jos Geboers and Willem Kort, who are working in the healthcare industry, especially in clinical pharmaceutical R&D, Health Economics, Outcomes Research and Patient Recorded Outcomes.  To that purpose Messrs. Geboers and Kort initiated the foundation of a consortium that includes all players, i.e. top listed pharmaceutical companies, medication packagers, health insurers and Royal DSM N.V.: “The Compliers Group” (DSM TCG).  DSM TCG wanted a way to be as certain as possible that patients were taking their medications at the correct frequency each day. They knew that, whatever solution they decided on, it needed to be “real time” since any delays in therapy could have serious health consequences. A novel system for measuring the time and quantity of drugs taken out of conventional, existing medication packaging or medication container, is used.  “Leading” versus “Bleeding” edge …

The existing medication package will do …

The system consists of conventional, existing medication blister pack (or “bottle”) of a given prescription drug furnished with “organic electronics” (circuitry, power supply), i.e. functional polymers and coatings, to print “the micromechatronic blister/bottle”. A “traditional” silicon RFID/NFC IC (Integrated Circuit) that has been especially designed for OtCM™ with integrated interfaces for i.e. clock and temperature functionality, provide the intelligence to identify data (date-time) of pills/capsules that have been taken out of the blister pack/bottle, whilst wireless Radio Frequency (RF) techniques (NFC, Near Field Communication) are able to transfer data wirelessly from the “OtCM™ enabled blister/bottle” onto DSM TCG’s webserver.

Driven by the intelligence of the RFID chip, embedded in the “mechatronic circuitry”, and the printed power supply (capacitator, battery), an electric current is circulating through the circuitry of the packaging at regular time intervals. As soon as a dosage is removed out of the packaging, the chip is activated. This information is stored. When in close proximity of a (NFC) reader,  the recorded information in the packaging will be transferred and stored in the server to populate the Therapy Compliance Database of active patients, under all regulatory recommended & required security and privacy conditions, locally and globally.

The standard existing medication blister package will do at a fraction of the traditional costs!

The concept of using the technology of printing functional polymers and coatings is an innovative approach. A large variety of  applications in real-life situations has been brought about, especially for purposes of identification of products and, consequently, the packaging of products.  The standard medication blister package will do at a fraction of the traditional costs!   Moreover, until now, traditionally available therapy compliance devices are extremely costly, even if mass-produced. Mass produced RFID-tags combined with polymer printing will introduce low-pricing schedules, based on factors of 90-95% reduction vs. currently available “traditional electronic” OCM devices, i.e. pill boxes or so-called “smart pill boxes”.

DSM TCG’s OtCM™ technology can be combined with GP Solutions (UK) Ltd’s patented and approved Dose Guard™ solution; a child resistant senior friendly secondary barrier that when applied to a blister pack will render it safe for use. Both “come with the standard, existing medication package”.  From surveys it has been identified that patients and health practitioners (physicians, medical specialists, pharmacists) only appreciate the enabling of OtCM™ right from the medication packaging. There obviously is no need for an additional, “stand-alone” therapy compliance measurement (recording) device separated from the medication package.

During OtCMâ„¢ we measure through the standard medication packaging:

(1) when the pill/capsule is taken,

(2) the location of the removed pill/capsule onto the blister packaging,

(3) the correct dosing schedule,

(4) an acoustic signal might prompt the for action,  data re: expiration date,

(5) production information re: temperature, batch IDs from the production line,  drug interaction alerts.

This real-time “interventional approach” is what stands apart from other compliance solutions.  In conclusion, it is clear that there are several technological approaches that are aimed squarely at the problem of medication compliance. Though these advances give our “inner geek” some encouragement, they are ultimately targeted at making sure that at-risk populations stay on track as they take medications to improve their health status. David Rosa, Willem Kort

You can find further information on compliance and evolving technologies, via Design Cognition’s sister site ‘The Pharma Gateway‘. Also, if you are interested in our forthcoming compliance workshops – let us know.

Contact Chris Penfold (chris@designcognition.com).